p at e n t s
Changing the rules of the game: addressing the conflict between free access to scientific discovery and intellectual property rights Miriam Bentwich A provisional patented paper application procedure could promote earlier disclosure of novel scientific knowledge.
© 2010 Nature America, Inc. All rights reserved.
A
major constraint on the advancement of scientific research in biotech is the growing barriers to free exchange of scientific knowledge associated with the increased number of patents linked to intellectual property rights (IPR). This matter, which can be tagged as the ‘secrecy threat’, has been addressed in numerous publications1–7, and can be described as essentially revolving around two issues. One issue concerns the possible reluctance of patent applicants and owners to fully disclose their acquired novel scientific knowledge through early and easily accessible scientific publications. The other issue was broadly termed the “tragedy of the anticommons” by Eisenberg and Heller and has been further developed by other scholars8–10. It involves the possible constraining of other scientists from using patented novel knowledge for further scientific research for economic reasons. Indeed, numerous empirical studies have shown that scientists delay scientific publication of research they expect to patent and are reluctant to freely share research results and materials with other scientists11–15. Other studies and judicial decisions have shown that, contrary to its intended purpose6,16,17, the patent system does not necessarily offer a practical incentive for patent applicants to disclose much information regarding their inventions in a comprehendible manner18–21. In fact, the notion of prior art, so crucial in determining the eligibility of a patent application with respect to its novelty, at best, significantly limits the grace period in
Miriam Bentwich is in the Department of Political Science, The Hebrew University, Mt. Scopus, Jerusalem, Israel. e-mail:
[email protected]
which potential patentees may publicly disclose information regarding their invention before a corresponding patent application is submitted22–24. Finally, additional case-inpoint research illuminates instances such as that of Myriad Genetics’ policy regarding its patented breast cancer genes and their mutations, where patentees exploited their IPR to increase their profits at the direct expense of sharing novel scientific knowledge10,25–27. Admittedly, there have already been extensive and contrasting attempts to address the challenge at hand3,28–30, the bulk of which revolves around practical steps that may be taken to mitigate the secrecy threat and its negative consequences for scientific research without deserting the patent system20,31–33. However, these practical steps appear to be flawed with respect to the two main concerns associated with the secrecy threat. Thus, suggested practical measures against the tragedy of the anticommons, such as patent pools and governmental compulsory licensing for use of patents, lack a theoretical justification from an IPR advocate’s viewpoint. Meanwhile, other suggested practical steps, like extending the grace period for ‘self prior art’ or using the US provisional patent application (PPA) option more extensively, could allow potential patentees to publish their scientific knowledge at an earlier stage and in a fuller manner. Yet these practical steps have so far neither obligated nor stimulated potential patentees to do so in practice. We present here an alternative and, we hope, more successful approach to tackle the secrecy threat without undermining the patent system. This is achieved by a revised mandatory version of PPAs, designed for patents in biotech and administered by leading
nature biotechnology volume 28 number 2 february 2010
scientific journals, which would be officially recognized by the US Patent and Trademark Office (USPTO) and subsequently by other patent offices as well. From optional PPAs to mandatory PPPAs Since 1995, the USPTO has offered the option to submit provisional patent applications34 that are easier and substantially cheaper to file than a full-fledged patent application35–37. Submitting a PPA is easier because, unlike regular patent applications, PPAs do not require the inclusion of the patent’s claims, which define the extent of the protection sought in a patent application in detailed technical terms. Additionally, PPAs do not necessitate discussion of relevant prior art or use of applicable legal terms. Instead, PPAs need only adequately describe the invention and its scope38,39. As a result, this type of patent application lacks fundamental ingredients of any full-fledged patent application, and therefore, patents cannot evolve directly from PPAs. However, PPAs allow potential patentees to secure an earlier valid ‘priority date’ (that is, official filing date) for their future patented invention before the latter is fully prepared, thereby decreasing the chances of possible competition over their inventions36. Such an advantage, though, is granted only if two conditions are met. First, the nonprovisional patent application must be submitted no later than 12 months past the filing date of the PPA. Second, the provisional application must adequately provide a written description of the full scope of the invention explicated in the later full application36,39. Additionally, when these two conditions are met, and a corresponding non-US patent application is submitted within 12 months
137
pat e n ts How the PPPA procedure works Step 1: Creating required components for PPPA through online paper submission system
Optional data files
Submitted manuscript
Generate DTS certification(s)
Charge applicable funds
Send author DTS certification files
Step 2: Full patent application submission
Full patent application
Proof of article publication
Submitted manuscript & optional data files
DTS certification files
© 2010 Nature America, Inc. All rights reserved.
Step 3: PPPA validity determination by USPTO
Condition 1: FPA due no later than 12–18 months past DTS certification date
Condition 2: Submitted manuscript and optional data files sufficiently disclose the invention described in FPA
Figure 1 A graphical outline demonstrating how the PPPA procedure can be practically employed. PPPA, provisional patented paper application; DTS, digital time-stamping service; FPA, full patent application; USPTO, US Patent and Trademark Office.
after the filing date of the US PPA, in principle, the filing date of the PPA may also serve as the priority date for the non-US patent application. Consequently, US PPAs can be used in conjunction with other patent offices (e.g., the European Patent Office and Japan Patent Office), thereby potentially expanding the grant of IPR beyond US soil. As already mentioned, although PPAs theoretically enable their submitters to share their novel knowledge with other researchers, they do not obligate patent applicants to do so. In fact, because they are not full patent applications, PPAs constitute an anti-incentive for sharing novel scientific knowledge outside the patent system. For instance, if a patent applicant is unable to submit the full patent application within the allowed oneyear period, the applicant will lose the ability to patent the invention, at least insofar as it is explicated in the early publication as the latter now constitutes patent-blocking prior art22. The importance of the PPA procedure is that it opens the door to a contingent acknowledgment of underdeveloped and informally submitted patent applications.
138
Hence, PPAs are informally submitted in the sense that, for themselves, they are neither published nor examined by the USPTO; and they are underdeveloped (by design) because they purposely accept patent applications lacking fundamental ingredients like claims and the discussion of prior art, as long as these applications contain a sufficient description of the invention and its scope. Consequently, in principle, a scientific paper that includes a description of an invention’s purpose and the method(s) used to attain it may qualify as a PPA. What’s more, insofar as the content and submission date of such a paper can be verified, the paper need not be physically submitted to USPTO before the filing of the full patent application, because other than recording their existence, USPTO does not execute any action with regard to PPAs. From this perspective, therefore, scientific publications would not constitute an external prior art, undermining the eligibility of patent applications. Instead, such publications, if recognized as provisional patented paper applications (PPPAs), would provide the very same protection that traditional PPAs grant a future intended patent, including their
supposed compatibility with the regulations of non-US patent offices. At the same time, contrary to the existing model of PPAs, the suggested PPPA alternative version will obligate patent applicants to share their novel knowledge with colleagues through scientific publications (Fig. 1). Thus, given the proper tools for date and content verification, PPPAs may be entirely administered by peer-reviewed academic journals instead of the USPTO, thereby further binding such provisional patent applications to scientific publications, while significantly lowering the fee charged for these applications. Moreover, because the scientific publication constitutes either the very PPPA or at least amounts to a significant integral portion of it (as will be explained later), there is a direct incentive for potential patentees to fully disclose the information concerning their inventions in the corresponding scientific publications. Otherwise, they risk their eligibility to use the PPPA as the basis for the full patent application, thereby undermining their ability to be granted with the desired patent and its conferred IPR. Similarly, potential patentees would be interested in disclosing that information as early as possible because any delay in the submission of PPPAs naturally increases the risk of potential competition over their inventions. Meanwhile, as the suggested PPPA procedure is inseparable from scientific publications, the potential patentee might very well choose not to use this procedure. Therefore, we suggest that the PPPA be defined as an obligatory step on the way to filing a full patent application in biotech. This being the case, it might also be advisable to extend the deadline for filing the full patent application for, say, another six months, so that potential patentees would have a larger safety net, covering instances where the paper is not immediately accepted. Moreover, paradoxically, the supposed reluctance of potential patentees to use PPPAs, should this be left to their choice, appears to be grounded on a sort of prisoner’s dilemma, where the assumed least risky choice is conflated with and mistakenly preferred over the best outcome choice, due to lack of cooperation40,41. Hence, lacking knowledge regarding the decisions of other potential patentees concerning the use of PPPAs and their entailed extra risks, a potential patentee would not want to take these extra risks. For, by taking such extra risks, she might put her invention in a more vulnerable position than competitors who choose not to use PPPAs. Yet, theoretically, if all potential patentees agreed (that is, cooperated among
volume 28 number 2 february 2010 nature biotechnology
pat e n ts themselves) to use PPPAs before their full patent applications were submitted, such an agreement would result in a much better outcome for all involved parties. By reaching this agreement, all PPPA submitters would be granted the following benefits: 1. Elimination of the extra risks associated with PPPAs, as the latter will entail now merely standard risks shared by all potential patentees. 2. Preliminary professional assessments of the invention’s validity through the journal’s peer-review process, thereby indicating whether the invention is worth investing in.
© 2010 Nature America, Inc. All rights reserved.
3. An earlier ‘certificate of quality’, should the scientific paper describing the invention be accepted, thereby potentially increasing the ability to raise more funds. 4. Possible advice for prepatenting improvements to the invention, leading to a potential increase in the patent’s value. Mandatory PPPAs are, therefore, justifiable, even from the viewpoint of potential patentees, while being an acceptable form of provisional patent application (PPA). At the same time, PPPAs address the first portion of the secrecy threat, regarding the possible reluctance of potential patentees to publicly share new scientific knowledge in a full and easily accessible manner. From theory to practice Assuming the employment of mandatory PPPAs is logically plausible, even from a potential patentee’s standpoint, it is still necessary to explain whether and how they can be applied in practice. Essentially, enabling valid and effective PPPAs necessitates that scientific publications provide papers’ submitters with trustworthy certifications of the date and content of the relevant information that is needed to constitute such PPPAs. That way, though PPPAs are not administered by a patent office, but rather by academic journals, PPPAs would be amply reliable for use by both potential patentees and the USPTO. Accordingly, to supply such trustworthy certifications, academic journals must comply with the following three requirements: 1. Provide authors, upon their request, with the necessary certification of the paper submitted for publication that describes the invention for which a patent may be sought.
2. Grant authors, upon their request, a separate certification for additional optional and unpublished data that they wish to include as part of the PPPA. Such certified but unpublished data contain materials that are not suitable for a scientific paper, but might be technically important for securing the full patent application (e.g., certain claims or additional figures). 3. Ensure that the granted certifications can be independently verified by the USPTO in a simple manner, once full patent applications are submitted. That is, allow the USPTO to (i) check the authenticity of these certifications and (ii) ensure that, insofar as the content of the certified manuscript is concerned, it is adequately covered by the finalized published paper. All of the aforementioned requirements can be realized by a combination of two existing and widely accessible technologies. One technology is the digital time-stamping service, issuing a trusted third-party time-stamp that associates a date and time with a digital document in a cryptographically strong way. The digital time-stamp can be used at a later date (e.g., by USPTO) to independently verify that an electronic document with a particular content existed at the time stated on its timestamp, thereby certifying the document’s content and creation date42,43. In this respect, it is important to note two points. First, a digital time-stamp, understood as a specific type of digital signature44, is legally supported and recognized by applicable legislations in many countries worldwide, and specifically by the United States45. Second, commercial digital time-stamping services46 are already available on the Internet with costs as low as 40 cents per use, making the financial barriers negligible to end-users. The other technology is the widely employed online paper submission processing software (e.g., Editorial Manager, Manuscript Central) already used, according to a recent study, by 76% of the peer-reviewed academic journals, and still growing47. The significance of these web-based computer programs is twofold. First, they can provide the option of date and content certification within the paper submission process, through seamlessly embedding the already available digital time-stamping toolkits that were designed to be set-in within a third-party software environment. Second, these programs include a bundle of features like financial transaction and automatic e-mail communication with the submitters of papers48. As such, these features provide further necessary support
nature biotechnology volume 28 number 2 february 2010
for employing PPPAs, like the ability to send authors their needed certified documents and their finalized articles’ proofs, as well as collecting the applicable fees for USPTO and the digital time-stamping service. PPPAs limit the effects of the tragedy of the anticommons Once used, PPPAs can also provide an adequate theoretical justification, from a patents’ advocate viewpoint, for significantly limiting the negative effects of the tragedy of the anticommons. This theoretical rationalization is based on patentees’ interest in securing the main benefit that is gained by their patents, namely IPR, as patents effectively grant patentees exclusive property rights over their inventions, even if for a limited period of time. The original notion of exclusive property rights and its justification is usually attributed to John Locke, the forefather of classical liberalism, though he simply used the term ‘property rights’49. In fact, Locke’s framing of property rights is still influential among contemporary libertarians and neoliberals, who usually perceive themselves as his successors, and therefore Locke’s thought is still relevant for contemporary discussions of exclusive property rights50–52. According to Locke, the initial justification for private exclusive property rights stems from an individual’s “mixing of his labor” in a previously unowned object. Thus, an individual, naturally, has exclusive ownership rights over his own labor, namely, it is his property. Consequently, by mixing his labor, it becomes inextricably part of the object, thereby rendering anyone else who would then use that object as effectively infringing the property that the first person has ‘invested’ in the object through his labor. By annexing her labor to the object, therefore, the individual restricts others’ right to use it, making it exclusively her own49,53. Acquiring a previously unowned object, then, necessitates that the new owner be the sole investor of labor in this object (be it directly from his own work, or indirectly through transfer of other people’s labor to his disposal). Inversely put, so long as other people have invested their direct or indirect labor in the object at hand as well, without being compensated for their loss of proportionate investment, no one can claim exclusive property rights over the object. From this perspective, therefore, a patent, pertaining per se to a new invention, involves an ownership of a previously unowned object, and may be granted to the patent applicant only if at the time the patent was granted, the applicant (and his party) could be
139
© 2010 Nature America, Inc. All rights reserved.
pat e n ts considered as the direct or indirect sole laborer(s) over the invention. However, by using PPPAs, potential patentees enjoy the labor that the anonymous referees have invested or mixed in the knowledge underlying the inventions intended to be patented. Similar to Locke’s example of a person’s mixing his labor in a natural and unowned land, thereby cultivating it and rendering it as more profitable, the anonymous referees’ work, as already indicated above, also assists in increasing the value of the knowledge at the basis of the intended patent. Consequently, in principle, a patent applicant has to ‘purchase’ the referees’ labor in enhancing the knowledge on which the invention is based, so that the applicant would be the only party to have invested her labor in the invention she is seeking to patent. Yet because the referees are anonymous, the patent applicant cannot transfer the payment to a particular person or group of people. Moreover, the referees themselves are able to perform their job (that is, labor) based on the current relevant scientific knowledge, acquired through the previous labor of other scientists, who have gained their knowledge on the grounds of their predecessors, and so on. In other words, only through compensating the scientific community as a whole can the potential patentee buy the labor, invested by other parties that are affiliated with this community in the theoretical knowledge, underlying the invention for which a patent is sought. This compensation would be made by unequivocally guaranteeing the community’s members an inexpensive license to use the theoretical knowledge behind the invention to which the community has contributed. Consequently, such a guarantee would be applicable, for example, to theoretical knowledge concerning particular mapped genes and their mutations (e.g., BRCA1 and BRCA2), but not to specific devices and services that further use this knowledge, as in the case of a breast cancer diagnostic kit. Still, it was precisely with regard to the type of patent associated with BRCA1 and BRCA2 and its potential damage to the free flow of novel scientific knowledge that the concern about the tragedy of the anticommons was expressed in the first place. Meanwhile, notice that the argument advanced here is not only theoretically plausible, but also practically allowable. Thus, the requirement to furnish other scientists with cheap licenses to use the theoretical
140
knowledge underlying a patented invention decreases the patentee’s income from such licensing. However, it also decreases the same patentee’s expenditures on getting similar licenses to other patentees’ theoretical knowledge. Moreover, the justified compensation scope is merely limited to theoretical knowledge used only within the conduct of research. Therefore, the pledge to inexpensive licensing for research endeavors neither covers using services and devices that use this theoretical knowledge, nor permits selling them without the explicit agreement of the patentee, thereby preserving the overall integrity of patentees’ IPR and their conferred privileges. Conclusions We have presented a novel and relatively easy solution to the secrecy threat entailed in patents and their undesired effects on the free access to scientific knowledge and to the advancement of biotechnological research. By suggesting a mandatory PPPA procedure, largely based on the already available and internationally recognized PPA procedure, we have demonstrated how the two main concerns associated with the secrecy threat can be addressed. We have shown how PPPAs may promote earlier and fuller disclosures of novel scientific knowledge and provide an ample justification for requiring patentees to grant inexpensive licenses for use of their inventions by other parties conducting research, while protecting the integrity of patents and IPR. COMPETING INTERESTS STATEMENT The author declares no competing financial interests. ACKNOWLEDGMENTS I am grateful to Zvi Bentwich and Isaac (Zahon) Bentwich for their invaluable comments on a previous version of this article. I also thank Moshe Maor and Avner de-Shalit for preliminary discussions regarding the article’s theme. Finally, I would like to express my gratitude to the Lady Davis Trust at the Hebrew University for its generous financial support that enabled the pursuit of this study. 1. Andrews, L.B. Nat. Rev. Genet. 3, 803–808 (2002). 2. Caulfield, T., Cook-Deegan, R.M., Kieff, F.S. & Walsh, J.P. Nat. Biotechnol. 24, 1091–1094 (2006). 3. Cook-Deegan, R., Chandrasekharan, S. & Angrist, M. Nature 458, 405–406 (2009). 4. Cukier, K.N. Nat. Biotechnol. 24, 249–251 (2006). 5. David, P.A. J. Inst. Theor. Econ. 160, 9–34 (2004). 6. Eisenberg, R.S. Yale LJ 97, 177–231 [225] (1987). 7. Holman, C.M. Trends Biotechnol. 25, 539–543 (2007). 8. Heller, M.A. & Eisenberg, R.S. Science 280, 698–701 (1998). 9. Shapiro, C. in Innovation Policy and the Economy, vol. 1 (eds. Jaffe, A.B., Lerner, J. & Stern, C.) 577–579 (MIT
Press, Cambridge, Massachusetts, 2001). 10. Merz, J.F., Kriss, A.G., Leonard, D.G.B. & Cho, M.K. Nature 415, 577–579 (2002). 11. Blumenthal, D., Campbell, E.G., Anderson, M.S., Causino, N. & Louis, K.S. J. Am. Med. Assoc. 277, 1224–1228 (1997). 12. Schissel, A., Merz, J.F. & Cho, M.K. Nature 402, 118 (1999). 13. Campbell, E.G. et al. J. Am. Med. Assoc. 287, 473– 480 (2002). 14. Grushcow, J.M. J. Leg. Stud. 33, 59–84 (2004). 15. Murray, F. & Stern, S. J. Econ. Behav. Organ. 63, 648–687 (2007). 16. 35 US Code § 112, 113. 17. Walsh, J.P., Cho, C. & Cohen, W.M. Science 309, 2002–2003 (2005). 18. Brenner v. Manson 383 US (1996), 519, 534. 19. Vitronics Corp v. Conceptronic Inc. 90 F3d (Fed. Cir. 1996), 1576, 1583. 20. Fromer, J.C. Iowa Law Rev. 94, 539–606 (2009). 21. Long, P. Univ. Chic. Law Rev. 69, 625–680 (2002). 22. 35 US Code § 102(b). 23. Tokkyo Ho [Patent Law] § 30(31) & 30(33). 24. Anonymous. European Patent Convention. Article 54 (European Patent Office, Munich, 1973). 25. Benowitz, S. J. Natl. Cancer Inst. 94, 80–81 (2002). 26. Borger, J. Rush to patent genes stalls cures for disease. Guardian (London) 15 December 1999, p.1. 27. Williams-Jones, B. Health Law J. 10, 123–146 (2002). 28. Caulfield, T., Gold, E.R. & Cho, M.K. Nat. Rev. Genet. 1, 227–231 (2000). 29. Fabrizio, K.R. & Di Minin, A. Res. Policy 37, 914–931 (2008). 30. Petherbridge, L. Maine Law Rev. 59, 339–384 (2007). 31. Bagley, M.A. Boston Coll. Law Rev. 47, 217–274 (2006). 32. Ebersole, T.J., Guthrie, M.N. & Goldstein, J.A. Intellect. Prop. Technol. Law J. 17, 6–13 (2005). 33. Franzoni, C. & Scellato, G. Proc. Acad. Innov. Entrepreneurship 2008, 388–401 (2008). 34. Anonymous. Federal Register. 73, 47535, 47540 (2008). 35. http://www.uspto.gov/web/offices/pac/provapp.htm 36. 35 US Code § 119(e), 120. 37. 35 US Code § 102(e). 38. 35 US Code § 111(b). 39. 35 US Code § 112 (first paragraph). 40. Axelrod, R. Am. Polit. Sci. Rev. 75, 306–318 (1981). 41. Rapoport, A. in Game Theory as a Theory of Conflict Resolution (ed. Rapoport, A.) 17–34 (Springer-Verlag, New York, 1974). 42. Cipra, B. Science 261, 162–163 (1993). 43. Skevington, P.J. & Hart, T.P. BT Technol. J. 15, 39–44 (1997). 44. http://www.digistamp.com/FAQts.htm#legality 45. Feng, H. & Wah, C.C. Inf. Manage. Comput. Secur. 10, 159–164 (2002). 46. http://www.guardtime.com; http://www.digistamp.com 47. Tananbaum, G. & Holmes, L. Learn. Publ. 21, 300– 306 (2008). 48. Wood, D. Learn. Publ. 14, 151–158 (2001). 49. Locke, J. in Two Treatises of Government (ed. Lasslet, P.) Second Treatise §5 (Cambridge University Press, Cambridge, 1967). 50. Machan, T.R. in Liberty for the Twenty-First Century: Contemporary Libertarian Thought (ed. Machan, T.R.) 209–226 (Rowman and Littlefield, Lanham, Maryland, 1995). 51. Narveson, J. in Liberty for the Twenty-First Century: Contemporary Libertarian Thought (ed. Machan, T.R.) 19–40 (Rowman and Littlefield, Lanham, Maryland, 1995). 52. Nozick, R. Anarchy, State and Utopia (Basic Books, New York, 1974). 53. Hailwood, S.A. Exploring Nozick: Beyond Anarchy, State and Utopia (Avebury, Aldershot, UK, 1996).
volume 28 number 2 february 2010 nature biotechnology
